MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	CA1040000
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator was alarming for service required alarm conditions indicating the internal battery had a charging issue and the oxygen blending module failed to function as designed.There was no harm or injury reported.There was no evidence the device was in patient use.The device was evaluated by the manufacturer's field service engineer (fse) and the internal battery charging issue was confirmed.The device's internal battery was replaced to address the issue.The "service required" alarm indicating an issue with the oxygen blending module o2 sensor was found in the ventilator's downloaded error log.For all instances of the alarm, the error log indicates that the code was generated due to a fault with the oxygen blender module's o2 sensor.The o2 sensor is used to monitor the oxygen level inside the oxygen blending module.The device's oxygen blending module was replaced to address the issue.This type of failure would not affect the ability of the device to provide therapy to published specifications.The device was tested and passed all final testing.

• Brand Name: TRILOGY
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24298946
• Report Number: 2518422-2026-004466
• Device Sequence Number: 9388633
• Product Code: CBK
• UDI-Device Identifier: 00606959022799
• UDI-Public: 00606959022799
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CA1040000
• Device Catalogue Number: CA1040000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown